4.28.5 Reporting Laboratory Accidents, Exposures or Hazards in Clinical Research, Biomedical Research or the Public Health Lab of East Texas
A. Purpose
To provide guidance in the event of a laboratory accident, exposure that occurs on the UT Tyler or UT HSC campus
B. Persons Affected
This policy applies to all UT Tyler employees, faculty, researchers and students.
C. Definitions
CDC – Center for Disease Control
CFR – Code of Federal Regulations
FR – Federal Regulation
NIH – National Institute of Health
TXHSC – Texas Health Safety Code
TAC – Texas Administrative Code
D. Policy
In the event a laboratory accident, exposure, or hazard occurs on on the UT Tyler or the UT HSC campus, and investigation by the appropriate personnel indicates that there is a mandatory reporting requirement pursuant to state or federal law, regulatory oversight agencies and/or UT System internal policy, the Office of the President and the Associate Vice President for Research Compliance and/or the responsible officer for Public Health Lab of East Texas (PHLET) will be notified immediately. Mandatory disclosures will be directed or delegated through the office of the President after consultation with appropriate UT Tyler or UT HSC safety officers (Environmental Health & Safety-EH&S, Clinical Accreditation and Compliance, Radiation etc.), Associate Vice President for Research Compliance and/or the Responsible Official (RO) for the PHLET, University Counsel, UT Tyler Compliance Officer, and/or UT System Office of General Counsel as warranted by the circumstances. If a report is generated, a copy will be forwarded to HR and the appropriate department, if required, to be maintained in the employee’s record.
Four main categories of laboratory accidents, exposures, or hazardous events that have the potential to occur are:
- Laboratory accidents during work with biological agents or in a biohazardous area that could result in physical injury, cuts, burns, abrasions, or fractures. Injury site could be contaminated with a biological agent in use.
- Events occurring during the handling of biological agents, infected specimens, or animals that could allow release of the agent to the environment or its undesired transfer to employees, animals, or cultures. Unwanted exposure or cross-contamination may occur without physical injury.
- Exposure to excessive amounts of radioactive agents.
- Loss of (or inability to account for) significant quantities of biological, radiological, or select agents stored in Research Labs or the PHLET.
E. References
TXHSC § 81.304
29 CFR § 1910
CDC/NIH (BMBL) Biosafety in Microbiological and Biomedical Labs
25 TAC § 289
7 CFR § 331 (plant select agents)
9 CFR § 121 (animal/overlap)
42 CFR § 73 (human/overlap)
61 FR 29327